US20090198295A1 - Intravascular Medical Device - Google Patents
Intravascular Medical Device Download PDFInfo
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- US20090198295A1 US20090198295A1 US12/423,605 US42360509A US2009198295A1 US 20090198295 A1 US20090198295 A1 US 20090198295A1 US 42360509 A US42360509 A US 42360509A US 2009198295 A1 US2009198295 A1 US 2009198295A1
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- tether
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/372—Arrangements in connection with the implantation of stimulators
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/372—Arrangements in connection with the implantation of stimulators
- A61N1/37205—Microstimulators, e.g. implantable through a cannula
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Abstract
An implantable medical device is configured so that all of the major components including a housing and attached leads are disposed within the vasculature of a patient. A tether extends from the housing of the device to an implant location where the tether is secured to tissue outside of the vasculature. In this manner, an intravascular medical device may be implanted at a location remote from final placement, delivered via the vasculature and anchored at the initial entry point.
Description
- This application is a continuation of U.S. application Ser. No. 11/342,734 filed on Jan. 30, 2006 and entitled “Intravascular Medical Device”.
- 1. Field of the Invention
- The present invention relates to medical devices and in particular, implantable medical devices.
- 2. Description of the Related Art
- Medical devices related to managing, treating and providing therapy for cardiac conditions have changed and improved dramatically since their inception. Cardiac pacing, as an example, originally required an external pulse generator that itself required external power. While providing life sustaining therapy, patients were tethered to the power source and of course, power failures could prove catastrophic. Portable, battery powered external pulse generators were developed and provided the patient with the ability to be ambulatory; however, the pulse generator had to be carried by the patient. Furthermore, pacing leads were exposed through the patient's tissue and extreme care had to be exercised to minimize the risk of infection or inadvertent withdrawal.
- Subsequently, fully implantable, battery powered pulse generators were provided in a hermetically sealed housing. This housing was rather large and was typically implanted in the abdomen of the patient, with leads extending to the heart. The size of such a device often made it rather uncomfortable and the implantation procedure was relatively invasive.
- As technology improved, implantable medical devices (IMDs) have become continuously smaller, while offering increased longevity, reliability and many more features and therapies. Epicardial leads that were attached to an external wall of the heart were replaced with endocardial leads that are implanted transvenously, thus becoming minimally invasive. With these smaller devices, the housing was no longer placed in the abdomen but instead was implanted subcutaneously or sub-muscularly, often in the pectoral region. A “pocket” is formed underneath the skin or muscle sufficiently large to receive the housing of the IMD. The exposed or proximal ends of the leads are then connected to the housing and the incision is closed. While now routine, this is still a surgical procedure that requires skill and the appropriate medical facilities.
- In general, patients are comfortable with these implanted devices and have a full range of motion, without interference or hindrance. Some patients feel the housing in the “pocket,” which may be physically and/or psychologically uncomfortable. Physically, some patients may press against the housing during certain physical activities making the housing noticeable. Even if not a hindrance or painful, simply “feeling” the presence of the device may remind that patient that they have a medical implant and/or medical condition and this alone may be troubling to that patient. Some patients develop a habit of pressing against the pocket and hence against the IMD and often rotating or twisting the IMD. Typically, IMDs that have one or more leads will have any excess lead length coiled under (or around) the housing of the IMD. Thus, frequent patient manipulation may cause portions of the lead(s) to twist or rub, potentially damaging the lead body or pulling the lead out of contact with the targeted tissue. This is sometimes referred to as “twiddlers syndrome.”
- As the size and capability of IMDs has greatly improved, use of these devices has naturally expanded. This results in greater knowledge and acceptance among the patient population as well as within the medical community. As a result, caregivers are using IMDs with more frequency and for new and diverse purposes. For example, pacemakers are used in patients with various bradyarrhythmias. In such a patient, the heart's intrinsic pacing function fails or is deficient and the IMD provides electrical stimulation to maintain the proper heart rhythm. Such therapy is well known and is referred to above with the early, external pulse generators. Recently, the medical community has been using pacing technology in patient's whose heart rhythm is actually normal. Heart failure patients often have normal rhythm and conduction; however, this disease causes the heart to enlarge. As a result the left and right ventricles are unsynchronized when they contract even though the depolarization waveform triggering such a contraction was “timed” properly. Using cardiac resynchronization therapy (CRT), the left and right ventricles are paced, leading to a mechanical “resynchronization” of the left and right ventricular contractions. This not only leads to better immediate hemodynamic performance, but the heart itself often remodels itself (reducing in size) leading to an improvement in the disease state.
- Not only are new therapies and treatments developing, implantable devices are now being used to collect sensor data for a variety of purposes. For example, implantable loop recorders (ILRs) are implanted subcutaneously and record cardiac data, unobtrusively, for extended periods of time. This allows robust medical data to be collected that, as a practical matter, may be otherwise unattainable.
- These are merely two examples that illustrate the ever increasing trend to beneficially use implantable medical devices with greater frequency and for a wide variety of purposes that extend well beyond cardiac care. This presents a challenge to some caregivers who might want to use a given device for their patient but do not have the necessary surgical qualifications to actually implant the device. While such a patient may always be referred to another doctor, this adds cost and burden, some patients may not follow through, and some caregivers may simply opt for other treatments in order to maintain their relationship with the patient.
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FIG. 1 is a schematic illustration of selected internal components of an intravascular medical device (IVMD) consistent with the teachings of the present invention. -
FIG. 2 is a schematic illustration of the IVMD including a tether and a lead. -
FIG. 3 illustrates an electrode incorporated into the tether. -
FIG. 4 illustrates an IVMD having multiple leads. -
FIG. 5 is a sectional view of a housing of the IVMD. -
FIGS. 6A-6B illustrate an IVMD having a lead and the tether coupled to a common end of the housing. -
FIGS. 7A-7 illustrate a system for deploying the lead and housing. -
FIGS. 8A-8D illustrate an IVMD having a tether with a lumen. -
FIGS. 9A-9D illustrate an IVMD having a tether with a lumen coaxial with a lumen through the housing and an attached lead. -
FIGS. 9A-9D illustrate multiple lumens. -
FIG. 10 illustrates a housing having multiple housing portions. -
FIGS. 11A-11B illustrate multiple housing components with a common tether. -
FIGS. 12A-12D illustrate a mechanism to attach a stylet to a housing component. -
FIGS. 13A 13B illustrate an IVMD with multiple housing portions. -
FIG. 14 illustrates an IVMD having multiple housing potions and multiple tethers. -
FIG. 15 illustrates an interaction of a stylet with both tethers ofFIG. 14 . -
FIG. 16 illustrates an IVMD with multiple housing portions. -
FIG. 17 illustrates an implanted IVMD. -
FIG. 18 illustrates the anatomical relationship between the subclavian vein and the clavicle. -
FIG. 19 illustrates the anatomical location of the cephalic vein. -
FIG. 20 illustrates an IVMD implanted in the superior vena cava having an auxiliary support member further anchoring the lead. -
FIG. 21A-21J illustrate the insertion and anchoring of an IVMD. -
FIGS. 22A-22B illustrate a tether anchor. -
FIG. 23 is a flowchart describing a process for implanting an IVMD. -
FIG. 1 illustrates an exemplary intravascular medical device (IVMD) 10. TheIVMD 10 is an implantable medical device that includes a hermetically sealedhousing 12 containing components 18 to control, power, and operate the device. Thehousing 12 is shaped and configured to reside entirely within the vasculature anatomy or within a given organ (e.g., the heart, lungs, kidney, pancreas, etc.) via the vasculature. In one embodiment, thehousing 12 has an approximate diameter of 6-7 French. TheIVMD 10 may have any number of functional areas including sensing, diagnostic, communications and therapy delivery. In the illustrated example, theIVMD 10 includes cardiac sensing, pacing and defibrillation as well as the ability to communicate with an external device through telemetry. - The
housing 12 includes aproximal header 16 and adistal header 16. The operative components 18 include apower source 20, such as a battery. One ormore capacitors 22 are provided that allow charge to be accumulated for rapid discharge to deliver a defibrillation or cardioversion pulse. Apulse generator 26 is coupled to thepower source 20 and provides electrical stimuli for cardiac pacing. - A
microprocessor 24, memory 36 (flash, EEPROM, ROM, RAM, DRAM, harddisk, etc.), analog to digital converter (A/D) 30,analog signal processor 28, and digital signal processor (DSP) 32 are positioned within thehousing 12. An externally actuatedswitch 42 is provided and may take the form of a reed switch that is closed by a magnet. Such aswitch 42 may be used to initiate a telemetry session withIVMD 10. - Alternatively, communication may be initiated directly by an RF signal or other appropriate transmission medium. A
telemetry module 34 provides the ability to transmit and receive data. Areservoir 35 is optionally included. The reservoir may provide a supply of a deliverable drug (e.g., insulin), genetic material, or biologic. TheIVMD 10 may provide for the release of the material on a given schedule or based upon sensed need. Some materials, such as insulin, may be dispersed as needed but are predictably used; that is, the likelihood of delivery over a given time period is high. Other material may be delivered on an acute basis. For example, a dose of a blood thinner, coagulant, anti-coagulant, or adrenaline is provided and released when necessitated. - An
accelerometer 40 may be utilized to provide an indication of patient activity for a rate response function and/or a relative position indicator; that is, physical position of the patient (e.g., prone). Finally, asensor array 50 is illustrated. Thesensor array 50 may sense any number of parameters such as temperature, pressure, velocity or other fluid flow characteristics, impedance, motion or size (e.g., ultrasound for wall motion and/or chamber size), oxygenation, glucose, or the level of any sensed chemical substance. It should be appreciated that while illustrated as contained within thehousing 12, thesensor array 50 may have appropriate external portions not shown. For example, if used as a pressure sensor, a transducing membrane will form a part ofhousing 12 or part of a lead coupled with thehousing 12, either physically or through telemetric connection (e.g., a body bus). Likewise, any additional component(s) forsensor array 50 will be included in this manner, as required. Cardiac data (e.g., electrogram (EGM)) will be sensed via one or more leads as explained below. In addition, thehousing 12 may include one or more electrodes incorporated into the structure of the housing 12 (i.e., an active “can”). - As indicated the
power source 20 may be a single use battery. Alternatively, the battery may be rechargeable. As such, anoptional recharging module 25 is illustrated. Therecharging module 25 may receive power from an external source, such as directed RF energy, which is converted and used to recharge thebattery 20. The RF energy may be collected via one or more antenna as discussed below, by using thehousing 12 as an antenna, or by incorporating a receiver into thehousing 12. Alternatively, or in addition, therecharging module 25 may use other mechanisms to generate power. In one embodiment, heat from within the patient is converted into current. In another embodiment, chemical energy from cells proximate the implant location is converted into electrical energy by the chargingmodule 25. The chargingmodule 25 may convert body motion into electrical energy. Such motion may come from multiple sources including without limitation gross patient movement (walking, exercising, etc.), lung motion (breathing), cardiac contractions, vasculature contraction (pulsitile blood flow), or fluid flow. The length of the unit provides the ability to harness mechanical power at one or more flexation points. Such flexation points may occur along the tether and/or in-between housing components. In this context, mechanical motion is converted into electrical energy by various mechanisms such as movement of a magnetic member within a coil. The chargingmodule 25 may also used photovoltaic conversion to generate electrical current. A light collected placed sufficiently close to the surface of the patient's tissue will receive enough ambient light to provide power. Various other techniques are available to recharge the battery and are considered to be within the spirit and scope of the present invention. The following documents are herein incorporated by reference in their entirety: U.S. Pat. No. 6,242,827, issued to Wolf et al. on Jun. 5, 2001; U.S. Pat. No. 6,768,246, issued to Pelrine et al. on Jul. 27, 2004; US Published Application 2004/0073267, published on Apr. 15, 2004; and US Published Application 2004/0158294 published on Aug. 12, 2004. - The
module 25 has been described in conjunction with a traditionalrechargeable battery 20 as a mechanism to recharge that battery. It should be appreciated that to conserve space, thetraditional battery 20 may be eliminated or greatly reduced in size (due to a decrease in reliance upon the battery). That is, the various mechanisms described to generate electrical energy from sources around theIVMD 10 may be used to directly power theIVMD 10, without first storing that energy in a battery. This concept is applicable to any of the various forms theIVMD 10. In one embodiment, providing power directly from module 23 is utilized when the IVMD has low or minimal power consumption requirements (e.g., periodic sensing). Thus, power is generated for internal operations and when communication is desired, external power is provided for e.g., telemetry functions, through inductive coupling or RF power transmission. Of course, theIVMD 10 may be completely dependant upon such power conversion for all of its functionality. Finally, as indicated, a smaller battery or capacitor may be provided to collect some amount of energy prior to use; either to mitigate against fluctuation in the source (e.g., movement stops for a period of time) or to provide an even power supply to mitigate against power fluctuations; that is, to provide a relatively stable DC source. -
FIG. 2 illustrates a lead 60 coupled with thedistal header 16. One or more electrodes are incorporated into thelead 60. As illustrated, lead 60 includes ahelical affixation member 64 that allows penetration into tissue to secure the distal portion of thelead 60 at a specific site. Thehelical affixation member 64 may serve as an electrode and/or the distal end of thelead 60, proximal to thehelical member 64, acts as an electrode. Acoil electrode 62 is positioned proximal to the distal end of thelead 60 so that when implanted, the coil electrode creates a defibrillation vector through an appropriate cardiac path with another electrode of theIVMD 10. The length of thelead 60 and the relative position of the electrodes are selected based upon the type of therapies, sensing and diagnostics provided and the implant location of thehousing 12. Thelead 60 may have other functions instead of or in addition to electrical stimulation or sensing. For example, a number of non-electrical parameters (e.g., pressure, temperature, velocity, chemical presence/concentration, etc.) may be sensed by providing an appropriate sensor. Thelead 60 may have a delivery device to deliver drugs, genetic material, or biologics from thereservoir 35. Such a delivery device may include aneedle 65 a for delivery into tissue; a disbursingtip 65 b (e.g., a porous surface for release into a fluid supply or against a larger surface area); or a variety of other delivery mechanisms. - The
lead 60 is connected to thedistal header 16. The connection may be a permanent, integral formation. That is, thelead 60 andhousing 12 are fabricated to form an integral unit or thelead 60 is permanently affixed to thehousing 12. Alternatively, thelead 60 is separable from thehousing 12, as explained below. As used throughout, the designations proximal anddistal header housing 12. It should be appreciated, that these portions may include a header in the traditional sense of an implantable medical device. That is, a separate portion from the remainder of the housing that includes various connection mechanisms (e.g., for receiving a lead connector pin). Alternatively, the terminology may simply refer to a given end or portion of thehousing 12 to facilitate description. - A
flexible tether 70 extends from and is securely coupled to theproximal header 14. At aproximal end 74, thetether 70 has an anchoring point. In the illustrated embodiment, a T-shapedanchor member 76 is attached to thetether 70 at the anchoring point. Theanchor member 76 includes one ormore suture ports 78 extending through themember 76. As indicated,IVMD 10 is implanted transvenously and theentire housing 12 resides within the vasculature or within an organ accessed via the vasculature. Thetether 70 extends from the implanted location of thehousing 12, through the vasculature and is anchored at or near the vasculature incision or puncture created for implantation. Thus, thetether 70 will fully or partially maintain the position of theIVMD 10. For example, if implanted in the superior vena cava, with apacing lead 60 extending from thehousing 12 into a cardiac chamber, blood flow and gravity (generally) will provide force against thehousing 12 in a direction towards the heart. With the anchor point fixed, thehousing 12 is prevented from traveling towards the heart and is thus secured. While suturing has been discussed, other methods of attaching or anchoring thetether 70 and/or theanchor 76 may be utilized. - The
anchoring point 74 allows for subsequent identification and access to theIVMD 10. That is, if the IVMD is replaced or modified, theanchoring point 74 is located and theIVMD 10 can be accessed or removed via thetether 70 along the same vasculature pathway. As such, theanchoring point 74 may optionally include a radiopaque marker, may be constructed of a biocompatible metal, or having other identifying mechanisms to aid in determining the location of theanchor point 74 at a later time via X-ray, MRI, or other imaging techniques. Alternatively, theanchor point 74 may be positioned sufficiently close to the surface of the patient's skin that its location may be felt by applying pressure to the area. - The
tether 70 is intended to secure the position of theIVMD 10 during the life of the implant. Accordingly, the tether material is constructed of a suitably strong, flexible, biocompatible material. The length of thetether 70 may include a drug eluting surface along the entire exterior, a portion of the exterior, or multiple distinct drug eluting surfaces may be provided. In some embodiments, thetether 70 may be used to temporarily secure theIVMD 10 until another anchoring mechanism is enacted (e.g., fibrotic growth). In yet another alternative embodiment, theIVMD 10 is intended to degrade within the body or pass harmlessly out of the body. For example,IVMD 10 may be a chemical sensor and thetether 70 secures theIVMD 10 at an appropriate location within the vasculature, counteracting the forces of pulsitile blood flow. Eventually, the sensor will dissolve and in such an embodiment, thetether 70 could likewise dissolve. Of course, thetether 70 provides a convenient mechanism to remove any such device thus providing for temporary implantation of a variety of medical devices, including pacemakers and defibrillators. - The
tether 70 is provided with an excess length. After implantation of thelead 60 andhousing 12, the desired length oftether 70 is determined. This final length should include enough excess to allow for normal movement of thehousing 12 within the vasculature as well as any variations that will occur due to patient movement, positioning, growth or other physiological variations. Thetether 70 is then cut at the appropriate location and anchored into place. The T-shapedanchor member 76, if used, is attached to thecut tether 70, either by suturing, mechanically clamping or using any other secure coupling mechanism. - As indicated, excess tether length is provided at the proximal end of the
tether 70 with an expectation that this excess will trimmed or remain unused. This allows for flexibility during implantation and minimizes the need to have multiple pre-configured devices to accommodate different patient sizes and implant locations. Conversely, a distal portion of thetether 70 will reliably remain intact. Thus, this portion of thetether 70 may be used to provide additional structure or functionality. - As illustrated in
FIG. 2 , anantenna 72 extends from thehousing 12 and may be contained within or affixed to an outer portion of thetether 70. Including theantenna 72 within thetether 70 provides a hermitic enclosure for theantenna 72 and any exposed feedthrough. The length, size, shape and configuration of theantenna 72 may vary from the illustrated embodiment and may extend for a relatively long length as compared to traditional implantable medical devices. Theantenna 72 may be used for communication and/or as an RF collector to receive power to recharge thepower source 20. Furthermore, while oneantenna structure 72 is illustrated, multiple antennas may be provided to facilitate different types of communication; to have a different antenna for transmission versus reception; to provide a separate power collector, to provide low and high power communication formats, to provide redundancy or for any number of reasons. One or more antennas may also be included in thelead body 60. -
FIG. 3 illustrates an alternative embodiment, wherein adistal portion 80 of thetether 70 functions as a lead having anelectrode 82 for sensing or stimulation. That is, theelectrode 82 is electrically coupled to thehousing 12 via thedistal portion 80 of thetether 70. This electrical coupling may be completely internal to and distinct from thetether 70 so that the mechanical properties of thetether 70 may be relied upon without adding stress or strain to what would be considered a lead body. Theelectrodes electrode 82 acts as a pacing electrode. In yet another embodiment,element 82 is a sensor such as a pressure sensor. Theantenna 72 ofFIG. 2 is not illustrated, though such an antenna may also be provided when thetether 70 includes one or more electrodes and/or sensors. The structure of thetether 70 may vary over its length. Thedistal portion 80 is not intended to be severed. The proximal portion, in one embodiment, is intended to be severed; thus, atransition point 84 may be present. Thetether 70 may have different materials and different construction from one portion to another or may have a unitary construction throughout. -
FIG. 4 illustrates anembodiment having lead 60 and lead 100 extending from the distal header 15. Thesecond lead 100 is illustrated as having atined tip 110 for securement as well as atip electrode 112 andring electrode 114.FIG. 4 is meant to illustrate that multiple leads may depend from thedistal header 16 and a variety of electrode and attachment (e.g., tines, helical tip) configurations may be employed. The use of two such leads is not meant to be limiting and any number of additional leads may be provided. Though not illustrated, one or more additional electrodes may be present ontether 70, as illustrated inFIG. 3 . -
FIG. 5 illustrates a sectional view ofhousing 12. In particular,multiple connection ports distal headers Port 150 includes acavity 160 shaped to receive a male connecting pin from, e.g., a lead. Aset screw 162 is positioned to advance into thecavity 160 and engage the connecting pin, thus securing the pin in place. Access to theset screw 162 is gained through a set screw opening 165 that may include a self sealing material, such as silicone to reduce fluid entry into the set screw opening after implantation. The configuration ofport 150 is repeated in each of the illustratedports lead 60, the lead pin will make contact with one or more electrical connectors disposed withincavity 160. Thetether 70 may also include a connector pin thus allowing for connection to thehousing 12 in the same manner as a lead. Of course, if thetether 70 includes electrode(s), antennas or other components appropriate electrical contact is made via the pin and cavity. In the absence of such components, the tether is simply mechanically secured within theport tether 70 may be integrally formed with theproximal header 14, thus appropriate access toports 154, 156 (if provided) is facilitated by the configuration of thetether 70 or by providing access through a portion of thetether 70. -
FIGS. 6A and 6B illustrate an alternative multiple lead configuration. In this embodiment, lead 60 is coupled with thedistal header 16. Asecond lead 100′ is coupled with theproximal header 14 as is thetether 70. In some applications, it may be desirable to have thesecond lead 100′ extend in the same direction as thetether 70, and as such, connection to theproximal header 14 is straight forward. Alternatively, and as illustrated, thelead 100′ is extended in the same direction as the first lead 60 (i.e., distal to the housing 12). When coupled with theproximal header 14, thelead 100′ is bent to achieve this configuration. While this is non-problematic for thelead 100′, movement of thehousing 12 via the tether 70 (e.g., retracting the housing 12) may be more difficult. To permit and facilitate such movement, thelead 100′ is bent to provide sufficient excess so that thehousing 12 may move relative to thelead 100′ without affecting the tip placement. It should be appreciated thelead 60, extending from thedistal header 16 also includes a certain amount of excess to address normal movement ofhousing 12 caused by pulsitile blood flow as well as some movement caused by withdrawal or retraction of thetether 70. - The curvature in the lead 100′ may simply be imparted during implant, with the
housing 12 remaining separate from thelead 100′ other than at theproximal header 14. Alternatively, as illustrated inFIG. 6B , aguide member 180 may be provided on an outer portion of thehousing 12. Thelead 100′ passes through theguide member 180 maintaining thelead 100′ in close proximity to the housing despite the imparted curvature and any resulting bias. In addition, by appropriately sizing theguide member 180 and providing a material with a low coefficient of friction (e.g., parylene, silicone) on theguide member 180 and/or thelead 100′, thehousing 12 may be slid relative to thelead 100′. - For clarity, lead 60 is not shown in
FIG. 6B . It should be appreciated that more than one lead may be coupled to theproximal header 14 in the manner illustrated. Furthermore, even if a single lead is employed, that lead may be coupled as illustrated by thelead 100′ inFIGS. 6A and 6B . This would allow all connections to be made at one end of thehousing 12 while still permitting lead advancement in a direction opposite to that of thetether 70. -
FIGS. 7A and 7B illustrate a system including a device that will aid in positioning any of the illustrated leads as well as thehousing 12. A steerable stylet (or catheter) 200 has ahandle portion 202 at a proximal end that includes controls that cause the stylet to flex or bend to facilitate intravascular navigation. A releasable clampingmember 210 is positioned at or near a distal end of thestylet 200. The clamping member is illustrated schematically inFIG. 7B as a sectional taken about the line A-A ofFIG. 7A . Upon actuation of thehandle portion 202, the clampingmember 210 opens and closes pivotingarms 212 so thatlead 100′ (or tether 70) is gripped or released. In this manner, thelead 100′ is directed to a target location and the clampingmember 210 is opened, releasing thelead 100′. It should be appreciated that thestylet 200 could be navigated as an over the wire catheter, thus following a previously positioned guidewire. The clamping of thelead 100′ would remain the same; however, the stylet/catheter 200 would be guided by the guide wire as opposed to being navigated independently. As indicated, such a device may be used to position leads coupled with either theproximal head 14 or thedistal header 16 and may be used to position thehousing 12. To position thehousing 12, the clamping member may be secured to a portion of an attached lead or to thetether 70. Implantation in this manner will be facilitated if the clamping occurs relatively close to thehousing 12. Alternatively, a lead extending from thedistal header 16 may be gripped at any position distal to thehousing 12, so that advancement of the lead withstylet 200 advances thehousing 12 as well. -
FIGS. 8A-8D illustrate another embodiment wherein asteerable stylet 250 is used to position thehousing 12.FIG. 8C is a sectional view taken about the line A-A inFIG. 8A andFIG. 8D is a sectional view taken about the line B-B inFIG. 8A . In this embodiment, thetether 70 has alumen 254 sized to receive thestylet 250. While the T-anchor 76 is illustrated as being coupled with thetether 70, it should be appreciated that the T-anchor 76 may be attached afterwards and hence is not utilized with thestylet 250 or the T-anchor 76 includes a throughbore that aligns with thelumen 254, thereby permitting passage of thestylet 250. In this embodiment, anabutment 252 is provided on an exterior of thehousing 12, as part ofproximate header 14. Thus, as thestylet 250 extends through thelumen 254, the tip of thestylet 250 will eventually reach and strike theabutment 252. Continued advancement of thestylet 250 will cause advancement of thehousing 12 within a vasculature pathway. If advanced too far, thetether 70 may be retracted, thus retracting thehousing 12. As such, thehousing 12 may be implanted at a target location by using thestylet 250 for forward advancement of thehousing 12 and thetether 70 for any necessary retraction. Leads (not shown in these figures) may be implanted with thestylet 200 previously described or similar mechanisms, if utilized.FIG. 8C also illustrates how the antenna 72 (if included) is positioned outside of the path defined bylumen 254, which is congruent withabutment 252. -
FIGS. 9A-9D are similar toFIGS. 8A-8D . In this embodiment, thelumen 254 extends through thehousing 12 as well as thelead 60. Thus, thestylet 250 may be advanced all the way through thetether 70, thehousing 12 and thelead 60 until it abuts an end of thelead 60. Thus, navigation of thestylet 250 will direct the distal end of e.g., lead 60 which pulls thehousing 12, ultimately positioning that component as well. -
FIGS. 9E-9H illustrate an embodiment havingmultiple lumens tether 70,housing 12 and lead(s) 60, with the second lead not illustrated. In this manner thestylet 250 can be directed through aspecific lumen lumens stylet 250. Further, the size, spacing and configuration of thelumens 254 may be varied. In an alternative arrangement, more lumens are provided through thehousing 12 and coupled with a corresponding lead than are provided through thetether 70. That is, thestylet 250 is directed through a lumen in thetether 70 and into a larger opening within theproximal header 14. The tip of thestylet 250 is then manipulated to manually select from a plurality of lumens each extending from this opening through thehousing 12 to a particular lead. - While direct manipulation of the
stylet 250 to select a desired lumen within thehousing 12 is one option, alternative arrangements are available. For example, the tip of thestylet 250 may be sized or shaped to specifically engage only one lumen through the opening in theproximal header 14. For each such lumen engaged, the tip may be exchanged or adifferent stylet 250 may be utilized. As an example, the largest tip may be inserted through the common lumen in thetether 70 and will only access the largest sub-lumen passing through thehousing 12. While occluding this larger opening, the next smaller tip may be utilized, and again a specific sub-lumen provides the only passage. - As described, the
IVMD 10 may include multiple leads with each of these leads attached or coupled with thehousing 12. Due to the size and implant location ofIVMD 10, particular configuration of thehousing 12 may make attachment of more than two leads cumbersome. In fact, in embodiments, the use of more than one lead may be cumbersome. In such a case, the present invention provides for the use ofmultiple IVMDs 10, each having one or two leads. Theseparate IVMDs 10 are in wireless communication so that their activities are synchronized. For example, one IVMD may provide atrial pacing and another may provide ventricular pacing. Themultiple IVMDs 10 may be completely independent and simply communicate to one another to synchronize timing. Alternatively, oneIVMD 10 may act to control the functions of one or more other IVMDs. Themultiple IVMDs 10 may be implanted through the same entry point and reside in the same anatomical location or proximate one another (e.g., both within the superior vena cava but offset from one another). Alternatively, the multiple IVMDs may be implanted from different locations and reside remotely from one another, while retaining wireless communication. -
FIG. 10 illustrates an embodiment whereinhousing 12 is separated into twocomponents housing components flexible interconnect 300, which may include one or more wires, cables or fibers for electrical or data communication. Alternatively, theflexible interconnect 300 may be a solely a mechanical coupling with eachhousing component housing components flexible interconnect 300 will mechanically connect theseparate housing components flexible interconnect 300 will act liketether 70′ as betweenhousing component 12 a andhousing component 12 b. That is, securing the proximal end oftether 70′ will ultimately retrainhousing component 12 b through theflexible interconnect 300. -
FIG. 10 also schematically illustrates asimplified tether 70′ as compared to thetether 70 illustrated in previous embodiments.Simplified tether 70′ is a generally linear, flexible member such as wire or cord and may be monofilament or multi-filar. Thesimplified tether 70′ could be secured to an anchor member such as the T-anchor 76, which is then secured to tissue. Alternatively, thesimplified tether 70′ could be sutured directly to tissue. -
FIGS. 11A and 11B illustrate another embodiment includingmultiple housing components housing component 12 a includes thelead 60 extending from adistal end 16. Thetether 70 extends in an opposite direction from theproximal end 14. A threadedreceptacle 310 is axially aligned with a lumen 254 (FIGS. 8-9 ) through thetether 70. Thesecond housing component 12 b includes a throughbore 320 sized to receive thetether 70. Thus, thehousing component 12 b may be added to or removed from thecomponent 12 a subsequent to implantation ofcomponent 12 a. - The
housing component 12 a includes one ormore receiving channels protrusions detents protrusions 316 internally via a mechanism that is not illustrated; thus, providing a secure locking mechanism. Alternatively, the spring bias of theprotrusions 316 may be overcome by applying sufficient force in an axial direction. Thus, a locking action is formed that will maintain the connection of the twohousing components - In
FIG. 11B ,housing component 12 a is coupled withhousing component 12 b. Also illustrated is astylet 322 having a threaded, taperedtip 326. Thestylet 326 is inserted through thelumen 254 with thetether 70. Thestylet 326 is advanced until thetip 326 reaches the threadedreceptacle 310. Rotation of thestylet 326 then causes the threadedtip 326 to engage thereceptacle 310. Once so engaged, liner movement of thestylet 322 will correspondingly move thehousing component 12 a (and 12 b if coupled as illustrated). Furthermore, once fully engaged, rotation of the stylet in a clockwise (with standard threading) direction will rotate thehousing component 12 a. Use of thestylet 322 in this manner allows for greater positional control of thehousing 12 a within the vasculature. While retraction of thetether 70 allows for gross movements, the engagedstylet 322 permits more precise movement which facilitates the attachment or detachment ofhousing component 12 b, among other things. - In one embodiment, the
stylet 322 is advanced through thetether 70 and threaded into thereceptacle 310. Thehousing receptacle 12 b is then advanced over thetether 70 using another stylet (see e.g.,FIG. 13B ) to push thehousing 12 b. When thehousing components stylet 322 is used (alone or in combination with tether 70) to holdhousing component 12 a in place and rotatehousing component 12 a to align withhousing component 12 b. When so aligned, thehousing components housing member housing component 12 a. Thus, the pin(s) 312 may be received anywhere along this channel 314. Relative rotation is permitted even whenprotrusions 316 and detent 318 (which may also be circumferential) are utilized. Alternatively, the detent(s) 318 may remain discrete and rotation of thehousing components -
FIGS. 12A-12D illustrate another embodiment ofstylet 322.FIGS. 12A-12C are side sectional views of a tip portion of thestylet 322. Initial engagement of the threadedtip 326 may be made more difficult since thehousing component 12 a is relatively free to rotate when implanted. Thestylet 322 in the present embodiment includes anouter sheath 350 and aninner rod member 352. The threaded tapered tip 324 retracts and extends from theouter sheath 350. - One or more pins 340 extend from the
outer sheath 350, with twosuch pins FIGS. 12A and 12D , thetip 326 is initially retracted within thesheath 350 and thestylet 322 is spaced fromhousing 12. Thestylet 322 is advanced until the pins 340 engage the openings 342, as shown inFIG. 12B . Rotation of thestylet 322 may be necessary to achieve this engagement. Again, the fit of the pin 340 to the opening 342 need not be particularly tight. Subsequent rotation of thestylet 322 will cause the pins 340 to abut a surface of the openings 342. Subsequently, therod 352 may be advanced via control at ahandle 360 and rotated so thattip 326 is threaded into thereceptacle 310, thus achieving a secure engagement so that subsequent manipulation of thestylet 322 will directly control thehousing 12. -
FIGS. 13A and 13B illustrate another embodiment utilizingmultiple housing components tether 70 is coupled withhousing component 12 a andhousing component 12 b is slid over thetether 70. A stylet/catheter 400 is provided that includes alumen 410 sized to receive thetether 70. Thus, thestylet 400 is also slid overtether 70 and is used to pushhousing component 12 b into engagement withhousing component 12 a. Though not separately shown, it should be appreciated that thestylet 400 may be releasably secured tohousing component 12 b so that advancement, retraction and rotation of thehousing component 12 b is facilitated. The manner in which stylet 400 is releasably secured tohousing component 12 b may vary and may include without limitation any of the coupling arrangements discussed herein. -
FIG. 14 illustrates an embodiment of amulti component housing 12, wherein thedistal housing component 12 b includes asupplemental tether 450. Thesupplemental tether 450 may be permanent or temporary. In either case, thetether 450 may be used to retracthousing component 12 b while a device such asstylet 400 is used to advance thehousing component 12 b. When permanent, thesupplemental tether 450 may be separately sutured at a distal end for securement or may simply be affixed to thetether 70. -
FIG. 15 is an embodiment similar to that ofFIG. 14 . In this embodiment, thestylet 400 includes an outwardly extendingtab 460. As thestylet 400 is rotated (in either direction), thetab 460 will engage thesecondary tether 450, causing thehousing component 12 b, to rotate with thestylet 400. Thus, thestylet 400 is used to advance and rotate thehousing component 12 b, without any other coupling required and thesecondary tether 450 is used to retract thehousing component 12 b. - More than two housing components may be coupled together to form or modify the
IVMD 10. As previously indicated, different parts of the same device may be separated between housing components. Alternatively or in addition, subsequent housing components may be added to provide additional therapies, diagnostics, capabilities or power. For example, anIVMD 10 may be implanted with a single use (i.e., non-rechargeable) battery. At a later point, another housing component may be added that includes a power supply to replace the depleted or soon to be depleted single use battery. Thus, the useful lifetime of a given device may be extended with a relatively minor procedure. AnIVMD 10 may initially be implanted having pacing functions and a later module may be added that provides defibrillation therapies.FIG. 16 illustrates one embodiment ofIVMD 10 having four joinedhousing components housing 12 and may take advantage of variations in the vasculature anatomy. - The
IVMD 10 may also be accessed post implant to add components (as discussed above) or to exchange components. That is, rather than simply adding ahousing component 12 having anadditional battery 20, ahousing portion 12 having thebattery 20 is first removed over thetether 70 and anew housing portion 12 is added. In this manner, the lead(s) 60 may remain in place, while other portions of the device are removed, replaced or otherwise manipulated. To that end, it should be appreciated that thedistal header 16 may take the form of a full orpartial housing component 12 that remains in place and is tethered to allow other housing components to be manipulated. Alternatively, thetether 70 may be coupled with a distal portion of the lead(s) or lead connector. Thus, theentire housing 12 may be added/removed while the lead(s) remains implanted and tethered. Finally, it should be appreciated that the IVMD may provide a variety of functions including sensing, diagnostics and/or therapy. Thus, accessing theIVMD 10 via thetether 70 allows for other components to be exchanged without removing the entirety of the device. For example, chemical sensors may become depleted of a source material or catalyst and replaced in this manner. Similarly, longer term drug eluting member or drug reservoirs may be replaced. Such reservoirs may contain traditional pharmaceuticals and/or genetic materials or biologics. TheIMVD 10 may be used to deliver such agents (e.g., gene therapy) to a target tissue location. When necessary, theIVMD 10 is re-supplied without requiring complete extraction or the implantation of another device. -
FIG. 17 illustrates anIVMD 10 implanted within thesubclavian vein 504 and extending into thesuperior vena cava 506 of aheart 500. Thelead 60 is illustrated as being an atrial pacing lead and adistal tip 64 is affixed within theright atrium 502. Multiple additional leads may be included. Thetether 70 extends from theproximal header 14 of thehousing 12 through thesubclavian vein 504. Theproximal end 74 of thetether 70 exits thesubclavian vein 504 at aninitial entry point 600. Theproximal end 74 is secured to tissue surrounding theinitial entry point 600, by e.g., the T-shapedanchor 76 which is sutured to the tissue. As pulsitile blood flow, directed towards theheart 500, and patient movement will cause movement of thehousing 12, a sufficient amount of slack material is provided along the length of thetether 70. - The position of
housing 12 illustrated inFIG. 17 is non-limiting. If desired, thehousing 12 may be positioned closer to theinitial entry point 600, thereby increasing the length of thelead 60. Conversely, thehousing 12 may be positioned closer to or even within theheart 500, increasing the length of thetether 70 and decreasing the necessary length of thelead 60.FIG. 18 illustrates the position of theheart 500 relative to thesubclavian vein 504 as well as theclavicle 620. In some embodiments, it may be desirable to position thehousing 12 within thesuperior vena cava 506 below (towards the heart 500) theclavicle 620. This avoids any potential for “subclavian crush” wherein leads or components within the vasculature are compressed between the clavicle and the first rib (not illustrated). The size and nature of a givenIVMD 10 will determine whether this is or is not a concern. Due to its size, shape and material properties, this will generally not affect thetether 70. Furthermore, implantation via thesubclavian vein 504 is only one entry site and others may be utilized. - As illustrated in
FIG. 17 , theinitial entry point 600 may be positioned quite distant relative to the location of thehousing 12.FIG. 19 illustrates the position of thecephalic vein 660 which flows into thesubclavian vein 504 and is accessible along thearm 665 of the patient. Thus, theinitial entry point 600 may be made in thecephalic vein 660 with thetether 70 then anchored to tissue in thearm 665. - After implantation, it may be necessary or desirable to access the
IVMD 10. Theproximal end 74 of thetether 70 is located and, e.g., thesubclavian vein 504 is accessed. Thehousing 12 may be moved or removed/explanted via thetether 70 and any associated leads 60 can likewise be moved, explanted, tested or otherwise manipulated. In addition, components may be added or replaced onhousing 12 without requiring removal. As identification of theproximal end 74 of thetether 70 facilitates such procedures, theproximal end 74 may include a radiopaque marker for identification with various imaging technologies, such as X-ray imaging or fluoroscopy. Of course, the entirety of thetether 70 may likewise be radiopaque. Alternatively, or in addition thereto, theproximal end 74 may be felt by applying pressure in the area. The configuration and anchoring of theproximal end 74 will determine whether this is possible and a balance is selected between patient perception of the proximal end, and the ability to locate thetether 70 manually, and the ease or pressure required to locate the tether manually 70. As yet another alternative, the subclavian vein 504 (or any vein/artery with a tether 70) is accessed via a new puncture distal to theproximal end 74. Thetether 70 is then located and manipulated. This may involve severing thetether 70 and if appropriate, reattaching or re-anchoring thetether 70. - As illustrated in
FIG. 17 , theIVMD 10 is secured at two locations; the first being where theproximal end 74 of thetether 70 is sutured and the second where thelead 60 is affixed to the atrial wall. In some embodiments, the nature of the lead 60 (or the absence thereof) may permit the distal end of that lead 60 or thehousing 12 to move freely and remain unsecured. For example, lead 60 may include a pressure sensor or temperature sensor. While such sensors may still include an attachment mechanism, it is possible to permit them to remain unattached. In addition to having thetether 70 anchored and having one or more leads 60 anchored, the flow of blood is directed towards the heart; which generally assists with maintaining the position ofhousing 12 as this flow generates force against the anchored portion of thetether 70. This represents a relatively simple implantation procedure in that additional retention mechanisms are not required. - As indicated, the
subclavian vein 504 andsuperior vena cava 506 are not the only potential implant locations. A variety of other locations will be able to utilize blood flow and gravity in combination with thetether 70 to secureIVMD 10. Of course,IVMD 10 may be implanted in other locations wherein this effect is not available or sufficient. In addition, there may be other reasons to further secure various portions ofIVMD 10. In one embodiment, retractable members are provided that expand against a vessel wall to secure theIVMD 10. The retractable members are collapsed for subsequent movement or explanation. Such structures are illustrated in published PCT application WO 2004/110263 which is herein incorporated by reference. -
FIG. 20 illustrates anIVMD 10 implanted in substantially the same position as illustrated inFIG. 17 . In this embodiment, anexpansion member 700 is expanded within thesuperior vena cava 506.Expansion member 700 presses thelead 60 against an interior wall of the vessel, further securing thelead 60 in place.Expansion member 700 may be a self expanding member made from shape-memory material or from material having a spring force that is restrained by e.g., a catheter until deployed. Alternatively,expansion member 700 is mechanically expanded by a balloon catheter or similar deployment mechanism. The use of such a member is generally not required when both ends of the IVMD are secured and blood flow is not pulling against an implanted lead. Such an expansion member may be useful when thelead 60 is otherwise unsecured orIVMD 10 is positioned in a location where blood flow or other forces might negatively affect the implant. It should be appreciated that theexpansion member 700 may be used for one or more leads, thehousing 12, thetether 70 or any combination thereof. -
FIGS. 21A-21J schematically illustrate implantation of theIVMD 10. InFIG. 21A , aneedle 810 is used to percutaneously pierce and enter avessel 802, such as for example the subclavian vein or cephalic vein. Theneedle 810 passes through theskin 800; in some cases access to thevein 802 may require piercing muscle or other tissue. Care is taken with the percutaneously puncture so that the needle does not pass entirely through thevessel 802 and into theunderlying tissue 804. - With the
needle 810 positioned within thevessel 802, aguidewire 815 is passed through theneedle 810 and into the vessel, as shown inFIG. 21B . While retaining theguidewire 815 in place, theneedle 810 is withdrawn as illustrated inFIG. 21C . Adeployment catheter 820 is inserted (FIG. 21D ) into thevessel 802 over theguidewire 815. A dilation catheter may be used to expand the original puncture or the tissue may be cut if the opening is insufficient. Depending upon the configuration of theIVMD 10, theguidewire 815 and/or thedeployment catheter 820 may be directed to the final implant location for a lead and/or for the housing of theIVMD 10. Alternatively, if a stylet or other external mechanism is utilized, thedeployment catheter 820 need only provide access to thevessel 802 and the length of penetration is selected as desired. - The
IVMD 10 passes through thecatheter 820 and enters thevessel 802. Again, multiple embodiments have been presented and the order of entry of certain components will vary accordingly. In this example, thelead 60 is directed first towards the implant site by e.g., a stylet directed through the lead or a stylet gripping an external portion of the lead; neither of which are illustrated in this figure. Trailing thelead 60 is thehousing 12 followed by thetether 70. When thehousing 12 and lead 60 are positioned, thetether 70 will include an excess amount exiting the incision site as illustrated inFIG. 21F . If additional intravascular securement mechanisms are utilized, they are deployed and configured. Thetether 70 is cut (FIG. 21G ) at severpoint 830 with a sufficient amount of excess provided so that upon anchoring, enough slack remains to allow expected movement of theIVMD 10 within the vasculature. The cut tether now has a newproximal end 840. - The new
proximal end 840 is secured. As discussed, there are multiple methods to attach thetether 70. As illustrated, the T-anchor 76 is mechanically attached to the new proximal end 840 (FIG. 21H ). The T-anchor 76 is then secured withsutures 850 to tissue proximate the incision site (FIG. 21I ). The puncture or incision through thevessel 802 will heal around thetether 70 and if necessary, this process may be aided by additional suturing or other techniques. The T-anchor 76 will remain below thesurface 860 of theskin 800, with the actual depth/distance from thesurface 860 determined by the medical practitioner, the depth of the incision, and the site of implant. It should be appreciated that theanchor 76 may be affixed to skin tissue, muscle or even the vasculature wall. The final position of theanchor 76 may therefore be subcutaneous or submuscular. As illustrated inFIG. 21J , theanchor 76 may be secured some distance from thevessel 802. This may require an additional minor incision, but allows the anchor point to be selected disparate from the puncture through thevessel 802. -
FIGS. 22A and 22B are side elevational sectional views that illustrate an external vasculature anchor 900 (EV anchor). As previously discussed, the T-anchor 76 is sutured or otherwise attached to tissue external to thevessel 802. TheEV anchor 900 is configured for direct attachment to an external wall of thevessel 802. TheEV anchor 900 has anarcuate attachment pad 902 with atether connection rod 904 depending therefrom. A tether attachment opening 906 is provided at a distal end of therod 904 so that thetether 70 is coupleable to therod 904. The rod 90 penetrates the vessel 802 (though the drawings are not meant to be to scale) and serves as the anchor for thetether 70. Thearcuate attachment pad 902 is large in comparison to therod 904 so that the force generated against thevessel 802 is dispersed over a larger surface area. - The
EV anchor 900 includes an interiorconcave surface 910 that is placed in contact with the vessel wall. Thissurface 910 is subdivided into afirst region 915 proximate the rod and the remainder of thesurface 920. Various drug eluting or traditional coatings may be applied to theinterior surface 910. For example, in thefirst region 915, where therod 904 enters thevessel 802, adhesives, steroids, coagulants or other materials are provided to facilitate the closure and healing of the puncture. Thesecond region 920 may be utilized for more adhesion or simply mechanical support. Theattachment pad 902 is meant to generally conform to the shape of the exterior wall of thevessel 802. To that end, thepad 902 may be flexible or malleable. Furthermore, while illustrated as extending about less the half the circumference of thevessels 802, it should be appreciated that thepad 902 may extend about a greater portion of thevessel 802 and may completely surround thevessel 802. -
FIG. 23 is a flowchart with an overview of the steps for implanting theIVMD 10 consistent with the teachings of the present invention and as described in greater detail above. The appropriate point of entry (e.g., subclavian vein) is identified and a percutaneous puncture is made (1000). If necessary, this opening is enlarged and any necessary catheter, guidewire or stylet is utilized to insert, deliver and attach the housing, leads and any other intravascular components of the IVMD 10 (1010). Thetether 70 extends from the now deliveredhousing 12 to the entry site and excess tether is cut and discarded (1020). Finally, the tether is secure external to the vessel so as to anchor the IVMD 10 (1030). - While various embodiments have been shown and described, the present invention is not meant to be limited by these embodiments. Furthermore, the embodiments may be combined in numerous ways without departing from the teachings of the present invention, even when not specifically illustrated. Variations and modifications may be made without departing from the spirit and scope of the present invention.
Claims (20)
1. An intravascular medical device (IVMD) comprising:
an intravascular housing having a proximal end and a distal end;
a circuit configured to operate the IVMD contained within the housing;
a first lead coupled with the distal end and having a fixation member at a distal end of the lead; and
an elongated tether coupled with the proximal end of the housing.
2. The IVMD of claim 1 further comprising:
an electrode disposed along the tether and electrically coupled to the housing through the tether.
3. The IVMD of claim 1 , further comprising:
an antenna coupled to the circuit through the proximal end of the housing and attached to the tether.
4. The IVMD of claim 3 , wherein the antenna is disposed within the tether.
5. The IVMD of claim 1 , wherein the tether further comprises a tether lumen extending through an entirety of the tether.
6. The IVMD of claim 5 , wherein the housing further comprises a housing lumen extending through the housing wherein the housing lumen is coaxially aligned with the tether lumen.
7. The IVMD of claim 6 , wherein the lead further comprises a lead lumen extending through at least a portion of the first lead and the lead lumen is coaxially aligned with the housing lumen.
8. The IVMD of claim 1 , further comprising a second lead coupled with the distal end of the housing.
9. The IVMD of claim 8 , further comprising:
a first tether lumen extending through the tether;
a first housing lumen extending through the housing:
a first lead lumen extending through the first lead; and
a second lead lumen extending through the second lead.
10. The IVMD of claim 1 , further comprising a tether anchor coupleable with a proximal end of the tether.
11. The IVMD of claim 10 , wherein the tether anchor is a T-shaped member including at least one suturing location.
12. The IVMD of claim 10 , wherein the tether anchor is a malleable, arcuate member having a rod depending from a concave surface, wherein the proximal end of the tether is coupleable to the rod.
13. The IVMD of claim 1 , wherein the IVMD is a pacemaker.
14. The IVMD of claim 1 , wherein the IVMD is a defibrillator.
15. The IVMD of claim 1 , wherein the IVMD is a pacemaker and a defibrillator.
16. The IVMD of claim 1 , wherein the housing has a diameter of approximately 6-7 French.
17. An intravascular medical device, comprising:
a housing deployable within a vascular structure;
means for delivering a therapy;
means for securing the housing within the vasculature to a site exterior to the vasculature.
18. An intravascular medical device (IVMD) system comprising:
a housing deployable within a vasculature structure;
means for delivering therapy;
means for securing the housing within the vasculature to a site exterior to the vasculature; and
means for delivering the housing to an implant location within the vascular structure.
19. The IVMD system of claim 18 , wherein the means for securing include a tether having a lumen and the means for delivering include a stylet configured for insertion through the lumen to direct movement of the housing.
20. The IVMD of claim 18 , wherein the means for delivering include a stylet having means for engaging an exterior of a lead coupled with the housing.
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